The PErineal Assessment and Repair Longitudinal Study (PEARLS): a national quality improvement initiative to improve the assessment and immediate, short and long term management of perineal trauma
| ISRCTN | ISRCTN28960026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28960026 |
| Secondary identifying numbers | 07/MRE12/2 |
- Submission date
- 20/08/2007
- Registration date
- 26/03/2008
- Last edited
- 27/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Sue Macdonald
Scientific
Scientific
15 Mansfield Street
London
W1G 9NH
United Kingdom
| Phone | +44 (0)207 312 3468 |
|---|---|
| Sue.Macdonald@rcm.org.uk |
Study information
| Study design | Randomised controlled trial using a matched pair cluster design. Maternity units are the unit of randomisation. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet. |
| Scientific title | |
| Study acronym | PEARLS |
| Study objectives | That the provision of an evidence based training package and its delivery to practitioners will lead to better outcomes for women following perineal trauma. |
| Ethics approval(s) | Thames Valley Research Ethics Committee, University of Reading. Approved in February 2007. |
| Health condition(s) or problem(s) studied | Perineal trauma |
| Intervention | A paired cluster design trial investigating the intervention of an evidence based, standardised training package delivered to midwives and obstetricians, in the assessment and management of perineal trauma. Twenty-four maternity units have been recruited and matched into 12 pairs. The training intervention will initially commence in one unit in each 'pair' (Group A) with it's matched partner continuing to provide usual care (Group B). All women in participating units will receive written information antenatally, at around 36 weeks. Following birth, further information about the study will be provided, and informed consent obtained on the Labour Ward, or prior to discharge. Women who participate will receive a pack to take home including a covering letter, 10-12 day questionnaire and a Self Addressed Envelope (SAE). Following receipt of the first questionnaire, the second questionnaire will be sent with an SAE at 3 months. Main study outcomes will be assessed at three months following cascading of the intervention in Group A units. The intervention will then be cascaded among Group B units. Please use the following contact details to request a patient information sheet: Sue Tohill/ Linda Lucking PEARLS Central Office Academic Unit of Obstetrics & Gynaecology University Hospital of North Staffordshire Newcastle Road Stoke on Trent, ST4 6QG, UK Linda Lucking: Tel: +44 (0)1782 552484; Fax: +44 (0)1782 552472; Email: Linda.Lucking@uhns.nhs.uk Sue Tohill: Tel: +44 (0)7880 942330; Email: sue.tohill@rcm-pearls.org |
| Intervention type | Other |
| Primary outcome measure | 21/03/2013: The previous primary outcome measures were incorrect due to an error at the time of registration. The correct primary outcome measure is as follows: Experience of perineal pain on daily activity at 10-12 days post birth. Previous primary outcome measures until 21/03/2013: Women's perspectives on what they consider important in the quality and experience of their care: 1. Infection and antibiotic treatment 2. Pain 3. Healing 4. Continence |
| Secondary outcome measures | 21/03/2013: The previous secondary outcome measures were incorrect due to an error at the time of registration. The correct secondary outcome measures are as follows: 1. 10 - 12 days post birth: 1.1. severity of perineal pain 1.2. need for suture removal 1.3. use of pain relief duirng the previous 24 hours 1.4. uptake and duration of exclusive breastfeeding 1.5. perineal wound infection 2. Three months post birth: 2.1. Edinburgh Postnatal Depression Scale (EPDS [14]) score of ≥ 13 2.2 timing of resumption of intercourse 2.3. satisfaction with the perineal repair. 2.4. duration of exclusive breastfeeding Previous secondary outcome measures until 21/03/2013: 1. Maternal physical and psychological well-being, assessed by the 10 day and 3 month questionnaires: 1.1. Incidence of perineal pain 1.2. Use of postpartum analgesia 1.3. Perineal wound infection 1.4. Uptake and duration of breastfeeding 2. Proportion of women who have an Edinburgh Postnatal Depression Scale (EPDS) score of greater than or equal to 13 at 3 months. |
| Overall study start date | 01/12/2005 |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1,000 |
| Key inclusion criteria | All women who sustain a second degree perineal tear or episiotomy in a participating unit during the study period will be eligible. To avoid problems with selection biases, overall outcomes for the centre will be ascertained using audit data from birth records. All births during a prespecified period will contribute to these analyses. |
| Key exclusion criteria | 1. Women under 16 years of age 2. Non-English speakers 3. Those who have suffered pregnancy loss |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
15 Mansfield Street
London
W1G 9NH
United Kingdom
W1G 9NH
United Kingdom
Sponsor information
Royal College of Midwives (UK)
University/education
University/education
c/o Mrs Louise Silverton
Deputy General Secretary
15 Mansfield Street
London
W1G 9NH
England
United Kingdom
| Phone | +44 (0)207 312 3535 |
|---|---|
| louise.silverton@rcm.org.uk | |
| Website | http://www.rcm.org.uk |
"ROR" |
https://ror.org/01swa5m73 |
Funders
Funder type
Charity
Health Foundation - Quality Improvement Initiative (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/02/2010 | Yes | No | |
| Results article | results | 23/09/2013 | Yes | No |
